Report series no.: RS/90/GE/04(PHL)
English only
REPORT TECHNICAL DISCUSSIONS ON HEALTH LEGISlATION
Convened by the REGIONAL OFFICE FOR THE WESTERN PACIFIC OF THE WORLD HEALTH ORGANIZATION Manila, Philippines 13 September 1990
Not for sale Printed and distributed by the Regional Office for the Western Pacific of the World Health Organization Manila, Philippines January 1991 WflO!WPRO LIBRARl llaniUJ, Phiiila_JI•
0 8 M ·~h 1991
NOTE The views expressed in this report are those of the participants in the Technical Discussions on Health Legislation and do not necessarily reflect the policies of the Organization.
This report has been prepared by the Regional Office for the Western Pacific of the World Health Organization for the governments of Member States in the Region and for the participants in the Technical Discussions on Health Legislation, which was held in Manila, Philippines on 13 September 1990.
CONTENTS
EXECUTIVE SUMMARY ............................................................................................................ I 1. 2. INTRODUCfiON .................................................................................................................. 1 PRESENTATIONS .................................................................................................................. ! 2.1 2.2 3. 4. Introductory remarks by the Secretariat (Annex 2) ................................................. 1 Background paper (Annex 3) ....................................................................................... 2
GENERAL DISCUSSIONS ................................................................................................... 2 CONCLUSIONS....................................................................................................................... 3 4.1 4.2 For Member States ........................................................................................................ 3 For WHO ........................................................................................................................ 4
ANNEXES: ANNEX 1 - AGENDA FOR THE TECHNICAL DISCUSSIONS ON HEALrn LEG ISLATION ........................................................................... 5 ANNEX 2 - FORTY-FIRST SESSION OF THE REGIONAL COMMITTEE MEETING -TECHNICAL DISCUSSIONS HEALTH LEGISLATION ........................................................................... ? ANNEX 3 - TECHNICAL DISCUSSIONS - HEALTH LEGISLATION (WPR/RC41/TD/2) .................................................................................... 11
EXECUTIVE SUMMARY
Health legislation was the subject of the Technical Discussions held in connection with the 41st session of the WHO Regional Committee for the Western Pacific. Dr Antonio 0. Periquet, Philippine Undersecretary for Hospital and Facilities Services, served as moderator. Participants in the Technical Discussions agreed that significant improvements in health may be achieved through the careful formulation or revision of legislation. The discussions revealed that in many countries, laws remain outdated or inappropriate to present health care needs. In countries where relevant legislation has been passed, implementation is often hindered by a lack of public awareness and resistance from interest groups. To deal with such problems, WHO was asked to increase its collaborative activities with Member States in the area of health legislation. The Organization was requested, in particular, to promote further exchanges of information and experience between countries on how legislation can positively contribute to the achievement of health-for-all goals. The participants recognized that while legislation for health should respond to the unique setting of each country, the usefulness of learning from each other should not be overlooked. Aspects of health legislation in 13 countries in the Western Pacific were discussed in some detail. Some of the salient points in the discussion are outlined below. The representative from Australia, for example, cautioned that while health legislation sought to provide consumer protection, among other things, the possible negative impact of "overregulation" also deserved attention. The representative from China said that health legislation was high on the list of eovernment priorities. A unit in the Ministry of Puhlic Health took charge of coordinating legislation for health; moreover, courses in health legislation had been established in most medical schools. The representative from Papua New Guinea cited the need for education of the public on the implications of health legislation, saying that many people remained unaware of their rights as target recipients of health care. The representative from the Philippines raised the issue of conflicting interests. As an example, a law on the use of generic names for drugs had recently been passed but its implementation had been "besieged with obstacles from special interest groups". The representative from Samoa pointed to outdated laws as a common problem in many South Pacific countries. Since 1959, health laws in Samoa had remained basically unchanged, making the country poorly equipped to deal with newer threats to health such as noncommunicable diseases and AIDS. The representative from VietNam, on the other hand, said a Public Health Act enacted the previous year incorporated regulations on traditional medicine, hygiene and sanitation, and the provision of curative and preventive drugs. A background document presented at the Technical Discussions lists five broad functions of health legislation: conferring rights, providing protection, promoting health, financing health care, and ensuring quality. The document also outlines some key health development issues of common concern to most countries and health care systems, such as the promotion of equity, efficiency and social justice. Health legislation initiatives in most countries of the Region must take into account two primary trends. First, the change in health care needs seen in the rise of such issues as life-style, behaviour, aging and environmental hazards; and second, an organizational trend towards partnerships. Legislation will play a central role in meeting these new needs.
1. INTRODUCTION
The topic of Technical Discussions at the forty-first Regional Committee of the Western Pacific Region was health legislation. This was the first time that health legislation had been selected for the Technical Discussions in any WHO region. The discussions were held in the afternoon of 13 September 1990, Manila. The agenda is shown in Annex 1. The objectives of the Technical Discussions were: to review the situation in the Western Pacific Region with regard to needs for (1) revised and new health legislation; (2) to review ways in which health legislation can support national health development; and (3) to discuss ways in which Member States, in collaboration with WHO, can further strengthen their capacity to analyse and update health legislation as necessary. Dr Antonio Periquet, Undersecretary for Hospital and Facilities Services, Department of Health, Philippines, was selected as Moderator for the discussions. In his opening statement he mentioned that health legislation was growing in scope and complexity at the country level, as well as at the international level. Consequently, there was increasing concern for keeping existing legislation up-to-date and using it to support current health development initiatives. The Moderator proposed that the discussions should begin with an introductory statement from the WHO Secretariat, followed by a general discussion which would be divided into two parts. The first part would provide an opportunity for countries to describe the current status of health legislation in their country. The second part of the discussion would focus more specifically on how health legislation could support health development activities and how WHO could collaborate in those activities.
2. PRESENTATIONS
2.1
Introductory remarks by the Secretariat (Annex 2)
The Secretariat indicated that historically in the Region, legislation had not played a significant role in supporting the health sector, particularly in relation to many priority health developments. The health-for-all movement had attempted to accelerate the use of health legislation in supporting health development. However, that had not really happened to a significant extent in most countries. A second concern was about the volume and relevance of existing legislation. It was not uncommon to find dozens of pieces of legislation dealing with the same aspect of health.
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2.2
Background paper (Annex 3)
The technical discussions background paper was prepared by Dr D.C. Jayasuriya, WHO consultant. The paper gave a brief summary of the status of health legislation in the Region. The paper then described the scope and functions of health legislation, showing how legislation is used in a variety of ways to address various health issues. The key message of the paper was that legislation should be viewed in a more comprehensive way and as a priority source of support to health development matters. The background paper also provided an analysis framework which could be used to review existing legislation as well as to formulate new legislation. The framework was based on the values expressed in the health-for-all movement.
3. GENERAL DISCUSSIONS
The discussion on health legislation by Member States was wide-ranging. It brought out the many significant health development issues facing countries of the Region and the concern to find ways in which health legislation could help to resolve them. All countries, with the exception of two or three, were trying to find an appropriate role for health legislation in their overall health-for-all strategies. The discussion offered a variety of alternatives. Participants discussed briefly the structure and process for legislative review and formulation. Most of them seemed to feel that part of their system was not a notable problem. There had been a change in the focus of health legislation from one of regulation and control to one of facilitation and empowerment. The discussions revealed a wide variety of methods and entry points for the solution of similar problems. Most of the discussions were not confined to biomedical issues of health. Many social concerns were expressed, such as equity of care, social justice, public empowerment, human rights, patient rights, ethics, and the expansion of the private sector. In many countries there was a demand for increased public participation in dealing with health issues. Leaders were struggling to determine how new health policy and strategy implementation could reflect those values. Much though was being given to the question of how legislation could support decentralization. There were several ways in which legislation was the medium for expressing and providing guidance on societal issues. For example in the Philippines, attempts were being made to promote equity through statutory incentives for health workers. Equity was also the main focus of the Generics Drug Act of the Philippines. Again in the Philippines, the empowering people idea was expressed in tobacco laws, relating to lifestyle changes. In VietNam, a more inclusive approach to societal issues was being taken, expressed in its completely new "public health law". In New Zealand, one of the many new issues being dealt with through legislation was patients' rights. A second major area of discussion was overall national health policy and strategy. It included topics such as system efficiency, cost containment, intersectoral matters and quality of care. Some new ideas were put forward on promoting intersectoral cooperation through
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the immunization programme. In New Zealand, attempts were being made to delineate fmancial accountability through legislation. A third area of discussion was organizational aspects of the health system, especially with regard to rights and responsibilities. Laws on the registration of doctors and other health workers did not always adequately define these. In Papua New Guinea, for instance, the strategy of decentralization had revealed the limitations of professional registration in defming rights, responsibilities and relationships between organizations and individuals. Consequently, new forms of legislation were required based on an organizational view of the functions of the various institutions and categories of health personnel. In this connection the role of legislation in management was also discussed, especially with reference to developments in New Zealand. The question of how legislation could accommodate rapidly changing technology was also examined. Australia's approach was to allow maximum flexibility to states and to the private sector so that they could respond to local needs and interests. A number of countries expressed a concern for their legislation in the area of mental health. Whereas legislation had previously emphasized protection against dangers related to mental disorders, it was more concerned now with the patients' rights and needs. Finally the role of legislation in health promotion was discussed. The programme areas most frequently mentioned in this connection were Tobacco or health, care of the elderly, noncommunicable diseases, and AIDS.
4. CONCLUSIONS
4.1
For Member States ( 1) In the area of existing legislation, the Meeting noted that many of the current laws were out of date and there was often a proliferation of overlapping statutes on particular subjects. It was recommended that Member States should share their experience on how to deal with this problem. (2) In the area of new legislation on specific subjects such as AIDS, organ transplants and environmental pollution, it was recommended that Member States should work more closely with each other since the effects of such laws go beyond national boundaries. (3) In the area of national development strategies, it was recommended that more efforts should be made to increase the awareness of policy-makers and managers of the vital role that health legislation can play in supporting these initiatives. (4) With a view to promoting a better appreciation of health legislation, Member States should develop public awareness programmes and exchange ideas on effective ways of involving the public in discussions on legislative reforms. (5) In selected areas, such as trade, commerce or pharmaceuticals, Member States may wish to collaborate in formulating appropriate legislation.
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(6) With a view to accelerating the process of reviewing existing laws and of drafting new laws, Member States may wish to consider setting up a body with multisectoral representation. 4.2 ForWHO (1) The meeting noted that as the scope and amount of materials on health legislation were rapidly increasing, there was an urgent need for improved methods of collecting, reviewing and disseminating this information to countries. As the role of health legislation in support of national development strategies was (2) becoming more apparent, it was recommended that WHO should develop and promote methods for improving the formulation, implementation and evaluation of health legislation. These methods should follow the guidelines outlined in the Technical Discussion background paper.
(3) To increase the capability of policy-makers and managers in formulating appropriate legislation, WHO should prepare materials and initiate training programmes. Training should include visits to other countries to study their approaches to drafting health legislation. Emphasis should be placed on priority areas such as decentralization, health insurance, quality of care and emerging health problems. (4) It was recommended that WHO should provide guidelines for Member States developing laws and regulations in selected areas. These should cover organizational and o~erational issues including that of the role and functions of different governmental agenctes. (5) In view of the shortage of health lawyers and legal draftsmen in some of the Member States, WHO should consider the possibility of extending technical support for the review of health legislation. WHO should support research and development in priority areas such as the (6) impact of rapidly changing technologies on legislation.
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ANNEX!
AGENDA FOR THE 1ECHNICAL DISCUSSIONS ON HEALTH LEGISLATION
1430-1435 1435-1450 1450-1515 1515-1530 1530-1645 1645-1700
Moderator's opening remarks Secretariat presentation: Health legislation General discussion Coffee break General discussion Conclusions and Moderator's closing remarks
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ANNEX2
FORTY-FIRST SESSION OF THE REGIONAL COMMITTEE TECHNICAL DISCUSSIONS HEALTH LEGISLATION
Introductory remarks by Secretariat The era of the Health for All movement in the Western Pacific Region can so far be characterized as a period of dramatic improvements in health for most of its people. There can be little debate as to the positive impact of reduced mortality and morbidity and the increased years of productive life on over all quality of life. Surely the increased coverage and quality of health services has contributed to this positive situation. We are not here, however, to simply praise our accomplishments. We are here because we all know that much more needs to be done. But more significantly, I believe we are here because as we review these needs and build tomorrow's vision for the health sector, we all can see many complex constraints to achieving our future goals. Consequently, the purpose of today's discussion is to clarify how health legislation can contribute to this formidable challenge. In outlining a way to more effectively use health legislation in supporting our health development efforts, I want to start by recalling that in all the early descriptions of primary health care and health for all, health legislation was included as a necessary supporting pillar. However, it is our conclusion that historically in this region, legislation has not played a significant role in supporting the health sector, particularly in relation to many critical health concerns. There are country exceptions of course. What is the purpose of health legislation? I believe it is very important to know why we are using legislation not just what we are legislating about. The question of "why" is particularly important in this period when so many complex changes are taking place. Health law serves a variety of purposes; namely, conferring rights, regulating behaviour as well as health-care products; authorizing programmes; regulating resources for health services; providing protection, promoting health, financing health services and safeguarding quality of care. In order to better use health legislation in the future, I believe it is important to understand its role in the past. In looking at the historical role of legislation during this century, we can see how closely it parallels the overall social and political concerns of that time. For example, in the latter part of the 19th century and in the early part of this century, legislation was designed to deal with specific issues: most notably the control of communicable diseases, and protection of public from unhygienic conditions. The next period saw a great emphasis on the regulation of health professions - the labour movement era. This period was clearly identified with 'a problem-based approach to viewing the world'.
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The next and present era is characterized as more policy based. The world view is not only to overcome obstacles, but more importantly it is one of setting goals, having a vision and striving to reach that goal. For us in health, legislation then was, and is still being used to support the organization of services, a more global approach. We can see this in health's concern for basic health services. Still somewhat of a controlling, regulating, protecting paternalistic view of the world; but broader in scope. I would suggest this was not yet a clean brake from the problem centered approaches. The health for all movement was meant to accelerate this conceptual brake from a problem centered focus to a vision oriented decision-making. Granted, health for all recognizes that there is a need to improve life styles; protect the environment and provide services. But the key message is that without peace, social justice, education, adequate income, and a useful role played by all people, none of the services in themselves will guaranty total health and a high quality of life. There is also a secondary explanation for the weak impact of health legislation, a managerial problem. Clearly, all countries have vast quantities of legislation. It is not uncommon, even in the smaller countries, to find from 30 to 100 pieces of legislation dealing with some aspect of health. In some cases, these laws are simply out of date and are therefore not enforced. However, in other situations, what appears to be good legislation is also not implemented. Like any other package of health actions, in order to be effective it must be manageable. That is it must have clear goals, a target audience, organization, finance and methods for evaluation. I am sure we can easily identify many laws which do not contain all of these critical elements. Consequently, it is quite likely that the reason for the weak contribution from health legislation, is a combination of administrative, structural and social factors. Today's health development context can be summarized very simply. In most countries, there are adequate health materials and services for most, if not everyone. There is also a keen awareness that the distribution of resources and the involvement of people in decisionmaking are the key issues in "health for all". Further we see that many types of structures and institutions are being experimented with a view to addressing these key issues; noting particularly social and health insurance programmes, decentralization approaches, and public participatory schemes. We are consequently looking at mechanisms which now must perform a variety of roles and actions; not just contain a disease. High on the list of roles is the concept of conferring rights. That is, enabling people to carry out responsibilities (fulfillment) that they can feel and relate to in the easiest manner, and that are closest to their home. In addition, we place high on the list of actions, the ideas of promoting health and lifestyle as socially good 'value.' Further, we still need to be able to appropriately respond to new diseases which will always be occurring. AIDS is not a unique phenomenon, but must be looked at as an opportune learning situation. It would appear therefore, that the form as well as the role of legislation is equally important. Which is to say, both the content and the process of legislation are important. For example, a lot is said about the needs for better management. The implication here is that we obtain a vision for health that more clearly defines 'the what' and 'the who' of involvement; this is not directed or regulated involvement but enabling involvement. Obviously, a very different role from the past for legislation. The background document that has been prepared for this discussion provides a more detailed explanation of the points that I have raised. In addition, this document outlines a methodology for reviewing existing legislation and preparing new legislation which we believe ensures that the legislative package will achieve the purpose for which the law was intended.
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This is done by relating the specific needs and concerns of a health development initiative, for example, improving equity, with the appropriate ways that legislation can support this need. For example, many of our equity concerns focus on providing decision-making authority to those people in need. Therefore, the conferring rights function of legislation must be clear and precise in the law dealing with this matter. Financing is another area with scope for much improvement. Financing schemes must not only raise revenue, but they must do it in an equitable way, distribute it in an efficient and equitable manner, and most importantly place accountability on the user. All these purposes must and can be more effectively supported through careful formulation of legislation taking into account the existing administrative procedures and structures that prevail in a country. Essentially, what we are saying is that health legislation has not really been drafted or used in the past in a systematic and pragmatic way. We have used or tried to use other means to develop, control, monitor and regulate health services. However, the current social and political environment has changed significantly. Within this new context the role of health legislation may just be the needed supporting mechanism. The question is how. This is new terrain; an unchartered territory. It is quite likely that new guidelines or frameworks will need to be developed. We believe that this forum today and what can be carried away as a result will be the first major step forward to achieve this objective, namely, more comprehensive and better conceived forms of health legislation in support of national health development for the 1990s and beyond.
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ANNEX 3 ORGANISATION MONDIALE DE LA SANTE
WORLD HEALTH ORGANIZATION
IUGIONAL OFFICE FOil THE WESTEI\N PACIFIC BUilEAU ll~GIONAL OU PACIFIQUE OCCIDENTAL
•
REGIONAL COMMI'ITEE
WPR/RC41/Technical Discussions/2 8 June 1990
Forty-first session Manila 10-14 September 1990
ORIGINAL: ENGUSH
HEALTII LEGISLATION
Technical Discussions
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Much of the health legislation that exists today hai ·;: accumUlated in response to needs that have since changed. ~j some cases new laws are needed, in others old laws obstruct:! 9evelopment. Apart from needing to catch up with change(~ .that have alr~dy taken place, health legislation is increasingly;: seen as a 'Way to introduce change and lead the way i.rif reshaping health care systems. This ·p aper outlines ~n appr9ach to updating national health legislation and providesL . b~kground infonnation for the discussion. r~
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WPR/RC41/Technical Discussions/2 page2
1. INTRODUCfiON
Legislation plays an important role in public health. While every country has many health-related laws and regulations, which in some cases have accumulated for centuries, few have developed a system to review and update them periodically and enact new ones as needed. Consequently, health care is often obstructed both by obsolete laws and by the lack of legislation on an increasing number of important health issues. This situation has made health legislation a pressing concern in many countries. This paper focuses on the function of health legislation in relation to national goals and objectives, and offers a framework for reviewing and updating it accordingly.
2. SCOPE OF HEALTil LEGISLATION
The term "health legislation" refers to a wide range of health-related laws. These commonly deal not only with individual rights but also with the health system, the environment, and any other matter that affects health. Examples of the special areas health legislation can include are given in Annex 1. "Health legislation" is to be distinguished from "health law", which is a broader term covering not only legal instruments but also judicial decisions, international treaties and conventions, customs and the opinions of jurists. "Health legislation", on the other hand, refers only to legal instruments such as acts, decrees, proclamations, ordinances or laws adopted or enacted by parliament or a similar supreme authority, and to regulations, by-laws and the like. Each area in its tum can contain many legal issues (see Annex 2 for an example of the range of issues that can be covered by a law dealing with health personnel). There is no universally applicable model. Each country has to decide how best to deal with each issue. It has to assess the urgency of the need, the political support available, the cost of implementation, and many other such matters. In countries with a federal government, the same issue often has to be dealt with differently in different states. Likewise, the provisions needed in an urban area, for instance, may differ from those needed in a rural area. Thus laws cannot usually be exported or imported without certain modifications.
In addition to the unique situation of each country, health legislation must respond to changing concepts of health. Traditionally the main concern was to deal with infectious diseases and inadequate sanitation, according to a narrowly defined biomedical model of public health. Now, in both developing and developed countries, there is more concern about noncommunicable diseases, mental health and diseases related to life-style and behaviour. Most countries also have a growing elderly population, increasingly dangerous and complex environmental health issues, and the need for new approaches to fmancing health services. All of this adds up to a much broader and more multisectoral view of public health, which calls for major adjustments; and health legislation can play a central role in making these adjustments.
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WPR/ RC41 /Technical Discussions/2 page3
3. SITUATION IN THE WESTERN PACIFIC REGION
Most countries of the Region periodically review their legislation, particularly in the areas of public health and professional registration. Tonga, for example, is reviewing its overall public health legislation. A number of proposals have been made for updating this legislation to reflect new technology, ideas and practices and abolish obsolete acts and regulations. A similar activity has been completed in Malaysia, particularly with regard to the registration of certain categories of health personnel. Malaysia is developing a national health insurance programme which will largely determine which health providers are eligible for reimbursement for the services they provide to insured people. Consequently, health providers such as radiographers, physiotherapists, pharmacists and others are anxious to see their roles appropriately defmed in legal statutes. Vanuatu has also reviewed its health acts inherited from the colonial era and proposed some new legislation. The challenge in legislation, as in other fields, is to evolve methods that are compatible with changing technology and social structures. For example, Fiji is undertaking the significant task of decentralizing a major portion of its health service delivery to the divisional level. In doing this, it .has to provide legislation that reflects the changing needs of the country. In Malaysia, a major effort is being made to structure a more comprehensive and participative health planning process. Traditionally, health planning at the national level was all done in the Ministry of Health. The goal now is to bring into the planning process all sectors and parties involved in health. Consequently, legislation to set up a national health counsel is being formulated. China has carried out activities to make managers more aware of how to use health legislation. In 1987, the first provincial primary health care legislation was enacted by the People's Congress of Heilongjiang Province. Chinese officials made a study tour to Canada, Japan and the United States in late 1987. This was followed by a national health legislation workshop. Another national workshop on the use of health legislation will be held in September 1990. In VietNam as well, a major effort is being made to increase the awareness of health staff on how to use legislation to support their health programmes. Here the emphasis is on training managers to use legislation in the area of health promotion. As more and more countries become aware of the need to update their health legislation, social and political reforms are also dictating the shape of new institutional structures. The trend towards the use of enabling legislation is particularly significant for public policy in the health development initiatives that are being taken in the Region.
4. THE FUNCfiON OF HEALTH LEGISlATION
Health laws serve a wide variety of purposes. These are summarized below as conferring rights, providing protection, promoting health, fmancing health services and safeguarding their quality.
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through immunization. Some laws empower communities to deal with problems such as pollution and disease vector breeding sites.
6. FRAMEWORK TO FACILITATE THE REVIEW AND UPDATING OF HEALTil LEGISLATION
In health legislation, the need for change can make itself felt more frequently than in some other branches of the law. Medical and scientific advances, technological developments, and changes in the system of health administration and management frequently call for legislative changes. Also new viruses and diseases can appear as in the case of AIDS. During the last five years, many countries have enacted new laws or regulations, or extended existing ones, to deal with HIV infection and AIDS. As medical techniques and approaches change, laws often must change too. Recently, for instance, Japan passed a new Mental Health Law to provide for a community-based approach to dealing with mental disorders, South Australia enacted a law on new artificial fertilization procedures, and the Philippines passed an act on the use of generic names for drugs. Ideally, there should be a unit within each ministry of health to monitor the application of existing laws and call for changes as needed. In some countries, this responsibility might be assigned to a national health council or law reform commission. Where no such body exists, a beginning may be made by commissioning a group of persons representing fields such as law, medicine and the social sciences to assess what is currently in place. The number of laws which relate to health in a given country ranges from 30 to 100, and many of them are accompanied by regulations or other subsidiary legal instruments. Some laws on other subjects contain provisions which have health implications, but can easily be overlooked by the health sector. In Malaysia, for instance, there is a Fishermen's Association Act, which authorizes associations to establish and run health centres, although nothing in its title suggests this. Legislation can be systematically reviewed in relation to its functional purpose and the development issues of the health system, as described above. Figure 1 shows how existing laws can be analysed in terms of their adequacies and inadequacies, thus indicating any gaps which may need to be filled. By using this model to analyse each law, it is possible not only to focus on its specific purpose, but also to identify any gaps that may exist. These gaps can then be closed by rewording the existing articles or adding new ones. The above provides guidelines on how to deal with some technical aspects of legislation. Equally important, however, are the administrative and management aspects of making and enacting laws. Administrative and managerial issues which most laws have to take into account include policy-making, resource allocation, coordination, implementation and evaluation. The responsibility for policy-makin& or defining objectives in relation to a law can rest either with a national health council or with a body formed to deal with a particular issue. A law on food and nutrition, for instance, may establish a food and nutrition advisory council to formulate policies. Alternatively, instead of making use of an existing mechanism or establishing a new one, the law itself can set out the policies which must be followed in implementing it.
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WPR/RC41/Technical Discussions/2 page7
Figure 1. Framework for analysing a law Health development issues Function of health legislation Confer rights Equity, efficiency and social justice Economies of scale lntersectoral cooperation Empowering people
Regulate behaviour/ products Authorize programmes and regulate resources for health services 1-'rovlde for financing of health care Exercise surveillance over quality of health care
The availability and proper allocation of resources are major determinants of the extent to which a law can be implemented. Adequate provision must be made for the appropriation and disbursement of funds. Public revenue, insurance, community financing and user charges are some of the ways in which these funds can be raised. In some cases, nongovernmental organizations provide voluntary funds. If fees are to be charged or taxes levied, the law must empower the authorities concerned to do this. Many health-related interventions have multisectoral implications and the law must therefore provide for coordination with all concerned agencies. Coordination can be called for either in general terms or in relation to specific activities. The agencies with which contact is to be established can be named or left to be determined as and when the need arises.
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WPR/RC41/Technical Discussions/2 pageS
There is a wide body of research and experience to support the belief that much of the ineffectiveness of legislation is caused by poor implementation. Implementation can be significantly improved simply by incorporating its requirements in the legislation itself. For instance, the responsibility for carrying out various provisions can be assigned to specifically named agencies or groups. By providing for a regular reporting system with regard to implementation, it is possible to monitor a law's effectiveness and decide what remedial measures must be taken.
An integral component of implementation is evaluation. Procedures for evaluation have to be built into a law in order to ensure that the law is implemented in such a way that the objectives can be realized. Evaluation must be a continuous activity; in some cases a legal requirement that an annual report on the implementation of the law must be published, for instance, will help draw public attention to the manner in which the law is being implemented. In formulating a draft law it is useful to consult similar legislative instruments adopted by other countries. For this, several publications exist, such as WHO's International Digest of Health Legislation, the ILO and F AO digests of legislative developments, the Commonwealth Law Bulletin published by the Commonwealth Secretariat, and UNFPA's Annual Survey of Population Law. When the draft is nearing fmalization, comments from the relevant government departments can be useful, and the relevant professional associations, manufacturers and patient groups should also be consulted.
7. SUMMARY
Health development initiatives in most countries of the Region must take into account two primary trends. The first is the change in health care needs seen in the rise of such issues as life-style, behaviour, aging, and environmental hazards, and the second is an organizational trend towards partnerships. The health sector can no longer be run simply by a government bureaucracy or a medical establishment. It has to be a harmonious multiplicity of organizations representing public, private, community, professional and consumer interests. Legislation will play a central role in meeting these new needs. This paper has outlined an approach enabling it to do so through the review of existing laws and the formulation of new ones as needed. It has suggested ways to deal with health development issues in legislation by considering its function in relation to national development goals. The paper has stressed that improving the design and implementation of health legislation is also an administrative task and has suggested ways to carry this out. It is hoped that with this background the discussions will show how Member States can use health legislation to support health development initiatives and ensure their successful implementation. ·
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SPECIAL AREAS OF HEALTil LEGISLATION 1
1.
Constitutional guarantees and safeguards relating to health and demarcation of legislative responsibility. Health-related international treaties, conventions and similar instruments. Regulation of different systems of medicine. Organization and administration of health care, health care facilities and services Economic aspects of health care Intersectoral cooperation Community participation Health research and health education Health manpower Disease control and medical care Public health, with particular reference to sanitation Family health and welfare Human reproduction and population policies Care of special groups Mental health Dental health Control of alcoholism, drug abuse and smoking Ethical issues and professional responsibility Transplants, death and related issues Nutrition and food safety Consumer protection
2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.
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WPR/RC41/Technical Discussions/2 page 10 Annex 1
22. 23. 24. 25. 26. 27. 28. 29. 30.
Pharmaceuticals, cosmetics and medical devices. Poisons, pesticides and other hazardous substances Occupational health and safety Environmental pollution Radiation protection Accident prevention Veterinary products and plants Sports and recreation Health information and statistics
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1HE ROLE OF LEGISLATION IN mE MANAGEMENT OF HEALTI-l PERSONNEL 1
Legislation can be an effective means of strengthening the management of health personnel. In providing for procedures, mechanisms and fmancing. the law can assist in implementing policies concerning the equitable distribution and effective use of health personnel. Legislation can: establish official government policy; define the functions of health personnel; regulate their geographical distribution; govern their working conditions and provide a career structure; provide for surveillance of their performance; lay down educational requirements for maintaining their competence; and allocate funds for training and development. Personnel managers may therefore turn to one or another type of law to improve the productivity and performance of health personnel. Le&islation affectin& the functions of health professionals Registration or licensing laws governing physicians, dentists, nurses, pharmacists and other categories of health professional spell out the scope of practice for the particular category. They may be unnecessarily constraining if they forbid the expansion of the functions of particular categories or their performance by others, even when these changes would be safe and necessary or advisable for expanding health service coverage. Conversely, legislation may authorize expanded functions - for nurses and medical assistants, for example; create new categories of workers for specific functions; defme the functions and education of allied health workers, such as medical assistants, school dental nurses and community health workers; or require a compulsory period of practical work in an underserved area. Registration or licensing laws usually include disciplinary provisions for improper performance of functions. LeiWation affectin& K®Kfaphic distribution of health workers Various legislative strategies have been devised to cope with the problem of geographic maldistribution of health workers and to support the general thrust of decentralization of the health services. Legislation can specify a period of required rural service as a condition of registration or licensure, provide incentives for rural health work, encourage the training and use of community health workers, and prohibit health professionals from undertaking practice in adequately served areas.
1 Prom lrl~ of HIIIMII Resowcn p HetJlt/1. R.eport ol a WHO Elpcrt Committee, WHO Tedmical R.eport Series No. 183. WHO, Geneva, 1989.
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WPR/RC41/Technical Discussions/2 page 12 Annex2
Legislation affecting the supervision of health personnel includes the following types: general legislation prescribing the duties of directors of public health agencies, health centres, hospitals, etc.; special legislation concerning the superviSion of particular categories of health worker, e.g. midwives, dental hygienists, nurse anaesthetists; disciplinary provisions in registration or licensing laws to ensure the competent performance of tasks and the maintenance of ethical standards; laws, ethical codes, and court decisions relating to malpractice and the liability of physicians and nurses for acts of subordinate staff. Legislation affecting working conditions may be an international instrument, such as the Nursing Personnel Convention adopted by the International Labour Organization (ILO) in 1977, or it may be national or subnationallegislation. Civil service regulations may prescribe rates of pay, steps for promotion, entitlements on retirement, etc. Legislation may provide for fringe benefits, including vacations, leave without pay, maternity leave, pensions, and housing entitlements. Finally, legislation can help protect workers against accidents, occupational diseases, and exposure to toxic chemicals. Le&isJation related to coptinuin& education and continued competence Legislation alone cannot ensure that continuing education will be of value, but some countries have introduced or are considering the introduction of legislation to reinforce various accepted methods by which health professionals maintain their competence. For example, registration or licensing laws may be amended to require a certain number of hours of approved continuing education or periodic re-examination as a condition of continuing registration or of licence renewal. Likewise, a certain number of hours of approved continuing education or periodic re-examination may be prescribed as a condition of maintenance of speciality certification either in national legislation or in the requirements of voluntary bodies.